Prospective Clinical Registry of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (S-ICD Korea Registry)
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Perioperative S-ICD Complication Free Rate up to 7 days post implant
研究概览
简要总结
S-ICD avoids the use intravascular leads and their associated risks, has been increasingly used for primary and secondary prevention of sudden death. The long-term safety and feasible of S-ICD system in Asian population with a smaller body size remain unclear. The investigators propose to perform a prospective study in Korean population to investigate the safety and feasibility of S-ICD for primary or secondary prevention of sudden cardiac death.
详细描述
The investigators propose to prospectively recruit 300 patients who are qualified to receive the EMBLEM S-ICD system by following the proposed BSC Patient Screening Steps in 10 sites in Korea. All patients will be follow-up as standard of care to collect acute procedural and device related complications as well as long-term, device related, clinical and patient reported outcomes. Follow up data will be systematically collected over 24 months post-implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years of age
- •Patients with conventional indications for ICD and;
- •Ability to provide informed consent and to complete the study and required follow-up
排除标准
- •planned cardiac surgery within 3 months of enrollment;
- •life expectancy <3 months;
- •indication for CRT-D or permanent ventricular pacing for new implant;
- •incessant ventricular tachycardia and/or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing; and
- •patients with unipolar pacemakers or implanted devices that revert to unipolar pacing
结局指标
主要结局
Perioperative S-ICD Complication Free Rate up to 7 days post implant
时间窗: 7 days
1 year S-ICD Complication Free Rate
时间窗: 1 year
2 year S-ICD Complication Free Rate
时间窗: 2 year
Perioperative S-ICD Complication Free Rate up to 30 days post implant
时间窗: 30 days
Percentage of inappropriate shocks for AF/SVT
时间窗: 2 year
次要结局
- Device related discomfort(2 year)
- Efficacy of S-ICD therapy for spontaneous VT/VF(2 year)